美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=PROMETHAZINE"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
PROMETHAZINE HYDROCHLORIDE 089477 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 1988/05/02 1988/05/02 MARSAM PHARMS LLC Discontinued
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 089647 001 ANDA CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML No No 1988/12/22 1988/12/22 PHARM ASSOC Discontinued
PROMETHAZINE HYDROCHLORIDE 085146 001 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG No No 1994/09/16 Approved Prior to Jan 1, 1982 INVATECH Discontinued
PROMETHAZINE HYDROCHLORIDE 085146 002 ANDA PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No 1994/09/16 Approved Prior to Jan 1, 1982 INVATECH Discontinued
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 040027 001 ANDA DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 15MG/5ML;6.25MG/5ML No No 1996/07/31 1996/07/31 HIKMA Discontinued
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 040151 001 ANDA CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML No No 1997/08/26 1997/08/26 HIKMA Discontinued
PROMETHAZINE HYDROCHLORIDE 040026 001 ANDA PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 6.25MG/5ML No No 1998/09/25 1998/09/25 CHARTWELL RX Prescription
PROMETHAZINE HYDROCHLORIDE 040372 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2000/06/08 2000/06/08 HOSPIRA Discontinued
PROMETHAZINE HYDROCHLORIDE 040372 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2000/06/08 2000/06/08 HOSPIRA Discontinued
PROMETHAZINE HYDROCHLORIDE 040428 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No Yes 2002/02/05 2002/02/05 COSETTE Prescription
PROMETHAZINE HYDROCHLORIDE 040428 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2002/02/05 2003/03/31 COSETTE Prescription
PROMETHAZINE HYDROCHLORIDE 040454 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/08/22 2002/08/22 TEVA PHARMS USA Discontinued
PROMETHAZINE HYDROCHLORIDE 040454 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2002/08/22 2002/08/22 TEVA PHARMS USA Discontinued
PROMETHAZINE HYDROCHLORIDE 040471 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2002/11/21 2002/11/21 MYLAN INSTITUTIONAL Discontinued
PROMETHAZINE HYDROCHLORIDE 040449 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 50MG No No 2003/02/27 2003/02/27 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040515 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2003/03/19 2003/03/19 AM REGENT Discontinued
PROMETHAZINE HYDROCHLORIDE 040504 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2003/04/11 2003/04/11 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040504 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No No 2003/04/11 2003/04/11 ABLE Discontinued
PROMETHAZINE HYDROCHLORIDE 040479 001 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No 2003/06/24 2003/06/24 WATSON LABS INC Discontinued
PROMETHAZINE HYDROCHLORIDE 040479 002 ANDA PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No No 2003/06/24 2003/06/24 WATSON LABS INC Discontinued
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